Docetaxel Followed by CEF (Cyclophosphamide, Epirubicin and 5-Fluorouracil) Compared to Docetaxel and Capecitabine Followed by CEX (Cyclophosphamide, Epirubicin and Capecitabine) as Adjuvant Treatment for Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Hoffmann-La Roche
Sanofi
AstraZeneca
Information provided by:
Finnish Breast Cancer Group
ClinicalTrials.gov Identifier:
NCT00114816
First received: June 17, 2005
Last updated: May 18, 2007
Last verified: May 2007
  Purpose

This study compares two chemotherapy regimens as adjuvant treatment for breast cancer. The study participants are randomly allocated to receive either 3 cycles of docetaxel followed by 3 cycles of CEF (cyclophosphamide, epirubicin and 5-fluorouracil) or to receive 3 cycles of docetaxel plus capecitabine followed by 3 cycles of CEX (cyclophosphamide, epirubicin and capecitabine). The study participants are required to to have a medium to high risk for breast cancer recurrence. The primary aim of the study is to investigate whether addition of capecitabine to a standard taxane/anthracycline regimen will influence recurrence-free survival.


Condition Intervention Phase
Breast Cancer
Drug: capecitabine
Drug: docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study Comparing Docetaxel Followed by Cyclophosphamide, Epirubicin and 5-FU to Docetaxel With Capecitabine Followed by Cyclophosphamide, Epirubicin and Capecitabine as Adjuvant Treatment for Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by Finnish Breast Cancer Group:

Primary Outcome Measures:
  • Recurrence-free survival

Secondary Outcome Measures:
  • Adverse event rate (CTCAE v. 3.0)
  • Overall survival

Estimated Enrollment: 1500
Study Start Date: January 2004
Study Completion Date: April 2007
Detailed Description:

This is an open-label, two-arm, randomized multi-center phase III trial to compare efficacy and safety of a taxane-anthracycline regimen to a taxane-anthracycline-capecitabine regimen as adjuvant treatment of early breast cancer with an intermediate-to-high risk of cancer recurrence.

Patients diagnosed with early breast cancer with an estimated risk of 25% or greater for distant recurrence within 5 years from the diagnosis will be randomly allocated to one of the following 2 arms (1:1):

  • Arm A -- 3 cycles of docetaxel 80 mg/m² intravenous (i.v.) (repeated on day [d.] 22); followed by 3 cycles of CEF (cyclophosphamide 600 mg/m2 i.v., epirubicin 75mg/m² i.v., 5-fluorouracil 600 mg/m2 i.v., repeated on d. 22)
  • Arm B -- 3 cycles of TX (docetaxel 60 mg/m² i.v., capecitabine twice daily 900 mg/m² given orally on days 1-15 of the cycle; cycle repeated on d. 22); followed by 3 cycles of CEX (cyclophosphamide 600 mg/m2 i.v., epirubicin 75mg/m² i.v, capecitabine twice daily 900 mg/m² on days 1-15 of the cycle; cycle repeated on d. 22)

Locoregional radiotherapy is given according to the institutional practice after completing adjuvant chemotherapy (Tx3/CEFx3 or TXx3/CEXx3).

All patients with ER and/or PgR positive disease will receive adjuvant endocrine therapy. This will consist of 1 mg p.o. anastrozole (ArimidexR) given for 60 months in women who were post-menopausal prior to chemotherapy (no menstrual periods for > 6 months) or of tamoxifen 20 mg p.o. for 60 months in women who were pre-menopausal prior to chemotherapy.

Use of trastuzumab is allowed in HER-2 positive disease.

Patients will be followed up for 5 years post-randomization.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be eligible for inclusion in the study, each patient must fulfill each of the criteria below.

  • Have provided written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
  • Be female and 18 years of age or older.
  • Have histologically confirmed invasive breast cancer.
  • High risk of breast cancer recurrence (> 25% within the first 5 years without adjuvant therapy, > 35% within the first 10 years) with one of the following:

    • Regional node positive disease (pN+; tumor cells or tumor cell clusters < 0.2 mm in diameter are not counted as metastases);
    • Pathological N0 and PgR- and tumor size > 20 mm.

Exclusion Criteria:

Patients who fulfill any of the following criteria will be excluded:

  • > 65 years of age.
  • ”Special type” histology (mucinous, papillary, medullary, or tubular breast cancer), when pN0.
  • ER, PgR and HER-2 status (via in situ hybridization or immunohistochemistry) not determined.
  • Presence of distant metastases.
  • Previous chemotherapy in the neoadjuvant setting.
  • Non-ambulatory or WHO performance status > 1.
  • Pregnant or lactating women. Women of childbearing potential (menstruating within 6 months of study entry or with no hysterectomy and age < 55) with either a positive or no pregnancy test at baseline.
  • Women of childbearing potential unless using a reliable and appropriate contraceptive method. (Post-menopausal women must have been amenorrheic for at least 6 months to be considered of non-childbearing potential).
  • More than 12 weeks between breast surgery and date of randomization.
  • Organ allografts with immunosuppressive therapy required.
  • Major surgery (except breast surgery) within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
  • Participation in any investigational drug study within 4 weeks preceding treatment start.
  • Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
  • History of another malignancy within the last five years except cured basal cell carcinoma of skin or carcinoma in situ of the uterine cervix.
  • Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not well controlled with medication) or myocardial infarction within the last 12 months.
  • Abnormal laboratory values:

    • Hemoglobin < 10.0 g/dL, neutrophils < 1.5 x 10^9/L, platelet count < 120 x 10^9/L;
    • Serum creatinine > 1.5 x Upper Limit of Normal (ULN);
    • Creatinine clearance (calculated per Cockroft and Gault) < 50 mL/min;
    • Serum bilirubin > ULN;
    • ALAT > 1.5 x ULN;
    • Alkaline phosphatase > 2.5 x ULN.
  • Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
  • Lack of physical integrity of the upper gastrointestinal tract or those who have clinically significant malabsorption syndrome.
  • Inability to swallow tablets.
  • Life expectancy of less than 3 months.
  • Unwilling or unable to comply with the protocol for the duration of the study.
  • Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114816

Locations
Finland
Department of Oncology, Helsinki University Central Hospital, Finland
Helsinki, Finland, FIN-00029
Sponsors and Collaborators
Finnish Breast Cancer Group
Hoffmann-La Roche
Sanofi
AstraZeneca
Investigators
Principal Investigator: Heikki T Joensuu, M.D., prof. Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland
  More Information

No publications provided by Finnish Breast Cancer Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00114816     History of Changes
Other Study ID Numbers: FBCG Protocol No. 01-2003, Roche protocol number MO17728
Study First Received: June 17, 2005
Last Updated: May 18, 2007
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Finnish Breast Cancer Group:
breast cancer
chemotherapy
adjuvant
capecitabine
docetaxel

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Docetaxel
Capecitabine
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on August 28, 2014